Luca Bucchini, Managing Director at Hylobates Consulting Srl, goes into detail regarding the regulation on botanicals in the EU following the ‘REFIT process.’

The European Commission has started to look at the regulations of botanicals in the EU through the so called REFIT process. In the words of the Commission, REFIT is “is a rolling programme to keep the entire stock of EU legislation under review and ensure that it is ‘fit for purpose’; that regulatory burdens are minimised and that all simplification options are identified and applied.”

What is the REFIT process for botanicals?

The European Commission is looking at whether current regulations are fit for purpose in the case of botanicals. This includes the Nutrition and Health Claims Regulation (NHCR) in reference to botanicals, and, in that context, at whether specific EU regulation of botanicals, and their quality, would have a positive effect. The process is ongoing, and it involves consultation with stakeholders. It is projected to end in 2017, but actual outcomes will probably be seen in 2018.

What is the hope of the industry with reference to botanicals?

As customary, there are different views. Most hope that health claims on botanicals may be addressed through a specific process, which would take into account traditional use. Traditional use is taken into account in the case of traditional herbal medicines, but not in the case of botanicals used in food or food supplements. Herbal medicines, however, while having a medicinal purpose, often have a similar composition of food supplements with botanicals.

Don't miss our new Brexit conference!

This unique event will help you address the impact on your business of the UK's exit from the EU, with presentations from Brexit thought-leaders, peer networking, debate and discussion.

This has raised doubts on the fairness of the different regulatory treatment (technically, whether it is proportionate). Also, regulating quality and legal use of botanicals would improve the quality of products, and permit the same plant food supplement to be sold across the EU. This is not currently the case because of national legislation, and different interpretations on the borderline between food supplements and medicines. Addressing the borderline issue would be a major step forward.

What are the views of others?

Some believe that further regulation of the sector, as is the case of regulation in general, is not necessary, and only minor modifications of the NHCR are warranted. Some others do not think that botanicals deserve any special treatment, when compared to other substances used in food. If tradition were recognised for green tea, why not for carnitine?

Others are keen to preserve the privileged treatment of herbal medicines in terms of efficacy (recognition of traditional evidence) while others are worried about additional GMP-like requirements for food supplements.

What is the likely outcome?

There is certainly pressure to address the issue of health claims; the current situation, though considered legitimate by the European Court of Justice, is not satisfactory as there is no legal certainty or adequate information to consumers. Also, most informed regulators agree that progress on quality is required. There seems to be therefore some backing for a tradition-based approach to claims (which remains contentious, however) and, more so, for regulating quality. However, there are formidable obstacles towards a solution, and it is hard to make a prediction.

How can industry react to REFIT?

Of course industry should collaborate to the consultation. It’s important for industry to understand that we need a market of European proportions. National markets may be cosier, as regulators are more lenient towards plant food supplements or favour herbal medicines. However, we need a EU-sized market for both, or industry will not be able to compete globally.

What are the pros and cons for consumers?

Consumers are not in a good position. On hold claims are not consistently regulated, and have not been assessed. There is no shared framework for addressing quality and safety issues.

So, REFIT, unless it ends with a very restrictive situation depriving consumers of currently legal safe products, is likely to be good for consumers.

Finally on a general note, imagine we are having this conversation in a year’s time, what will have changed in the world of botanicals?

We may regret that very little has changed. There is still no legal certainty, across the EU, when it comes to botanicals; there is no regulatory drive to improve quality, and no effective protection of consumers and little fair competition. But we also may be surprised to agree that the European Commission has managed to overcome obstacles, and greet at last a EU-wide market for botanicals, with better information and quality for consumers.